Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
CBER: IND Required Recordkeeping Unchanged 2225 127006 0
CBER: Part 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers Unchanged 288 7632 0 Form Form FDA 1571 Investigational New Drug Application
Form Form FDA 1572 Statement of Investigator
CBER: Part 312 Subpart B - IND Application; including content and form, safety reports, and annual reports Unchanged 7934 2518624 0
CBER: Part 312 Subpart C - Administrative Actions; including sponsor requests to FDA Unchanged 356 50884 0
CBER: Part 312 Subpart D - Responsibilities of Sponsors and Investigators; including investigator reports and sponsor notifications Unchanged 15200 578568 0
CBER: Part 312 Subpart F - Miscellaneous provisions including import & export requirements and foreign clinical stuides Unchanged 3253 93486 0
CBER: Part 312 Subpart I - Expanded Access to INDs for Treatment Use; including emergency use of IND Unchanged 304 5412 0
CDER: IND Required Recordkeeping Unchanged 76576 4137622 0
CDER: 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers Unchanged 649 17760 0
CDER: 312 Subpart B - IND Application; including content and form, safety reports, and annual reports Modified 75152 19051616 0 Other-Agency Guidance Document
CDER: 312 Subpart C - Administrative Actions; including sponsor requests to FDA Unchanged 896 112296 0
CDER: 312 Subpart D - Responsibilities of Sponsors and Investigators; including investigator reports and sponsor notifications Unchanged 42815 3418568 0
CDER: 312 Subpart F - Miscellaneous provisions including import & export requirements and foreign clinical studies Unchanged 12563 413715 0
CDER: 312 Subpart I - Expanded Access to Investigational Drugs for Treatment Use; including emergency use of IND Unchanged 4048 111572 0
Total burden requested under this ICR: 242259 30644761 0  
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